ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis

Astellas

Status and phase

Completed

Phase 1

Conditions

Patients With Impaired Renal Function and Haemodialysis

Treatments

Drug: ASP8825

Study type

Interventional

Funder types

Industry

Identifiers

8825-CL-0012

Details and patient eligibility

About

The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.

Enrollment

18 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body weight: ≥40.0 kg and <80.0 kg
Body mass index BMI: ≥16.0 and <30.0 [BMI= Body weight (kg)/(Height (m))2]
For Renal impairment patients: Patients with eGFR by GFR predictive equation for Japanese within < 50 mL.min/1.73m2 at screening and who is not undergoing dialysis
For Haemodialysis patients: Patients who receive dialysis at screening
Patients whose treatment regimen (including diet) for renal impairment or complications remain unchanged within 14 days prior to dosing, or patients who receive treatments (including diet) that need not to be changed during the period from 14 days before dosing to follow-up examination in the opinion of the investigator or sub-investigator.
Female subjects who agree use effective contraception starting at informed consent and throughout the study period

Exclusion criteria

Patients with a complication or history of the inappropriate for this study (except for a complication of primary disease for renal dysfunction, like diabetes etc., or complication of hypertension or anemia etc.)
Patients with a complication or history of recurring alimentary disease
Patients with a history of gastrointestinal surgical operation
Patients with a complication of severe heart disease
Patients with a complication or history of malignant tumor (However, a patient without recurrence of the malignant tumor for more than 5 years after the treatment may be eligible for the study.)
Patients judged ineligible by the investigator or sub-investigator based on the results of medical examination, vital sign, 12-ECG and laboratory test
Patients who have an Hb value <9g/dL at screening
Patients who received or are scheduled to receive any study drugs in other clinical trials or post-marketing studies within 120 days before screening
Patients who received or are scheduled to receive medications within seven days before the dosing of the investigational drug
Patients who previously received administration of Gabapentin or ASP8825